Fixed dose pharmaceutical composition comprising hyroxyurea and didanosine

Abstract

Pharmaceutical composition, containing fixed doses of hydroxyurea and didanosine, a method of manufacturing such composition, and to the use of the composition for the treatment of retroviral infections.

1 . A fixed-dose pharmaceutical composition comprising hydroxyurea and didanosine. 
   
   
       2 . A composition according to  claim 1 , comprising 200 to 1000 mg hydroxyurea and 200 to 400 mg didanosine. 
   
   
       3 . A composition according to  claim 1 , comprising 300 mg hydroxyurea and 200 mg didanosine. 
   
   
       4 . A composition according to  claim 1 , comprising 637.5 mg hydroxyurea and 325 mg didanosine. 
   
   
       5 . A composition according to  claim 1 , comprising 825 mg hydroxyurea and 250 mg didanosine. 
   
   
       6 . A composition according to one or more of the  claims 1 - 5  in the form of a capsule comprising one or more separately formulated pharmaceutical dosages of hydroxyurea and/or didanosine. 
   
   
       7 . A composition according to one or more of the  claims 1 - 6 , in which the one or more separately formulated pharmaceutical dosages consist of one or more tablets comprising hydroxyurea and/or didanosine. 
   
   
       8 . A composition according to one or more of  claims 1 - 7  in which the hydroxyurea is present in a tablet in compressed form. 
   
   
       9 . A composition according to one or more of  claims 1 - 7 , in which the tablet containing didanosine is enteric coated. 
   
   
       10 . A composition according to one or more of  claims 1 - 9  which exhibits decreased plasma levels for both active ingredients when taken with food. 
   
   
       11 . A composition according to one or more of  claims 1 - 9  which exhibits maximum plasma levels for both active ingredients when taken without food. 
   
   
       12 . A method of manufacturing a pharmaceutical composition according to one or more of the  claims 1 - 11 . 
   
   
       13 . A composition according to one or more of the  claim 1 - 12  which is administered to a patient in need thereof in a single dose once daily. 
   
   
       14 . A pharmaceutical combination comprising hydroxyurea and didanosine according to one or more of the  claim 1 - 13 , which is taken without food. 
   
   
       15 . A pharmaceutical combination comprising hydroxyurea and didanosine according to one or more of the  claims 1 - 14 , which when administered without food synchronizes the peak plasma levels for both compounds to within a 2.5 hour period. 
   
   
       16 . A pharmaceutical formulation comprising hydroxyurea and didanosine according to one or more of the  claims 1 - 14 , which when administered without food provides peak plasma levels for both compounds not more than 2.5 hours apart from one another. 
   
   
       17 . A pharmaceutical formulation comprising hydroxyurea and didanosine according to one or more of the  claims 1 - 16 , characterized in that when tested in an USP dissolution apparatus nr II, with 900 ml dissolution medium phosphate buffer at pH=6.8, and an impeller speed of 50 rpm, that the amount of each active ingredient released within 45 minutes is equal to or more than 75% (Q) of the labelled content for each active ingredient. 
   
   
       18 . A method of treatment of a patient suffering from an infection caused by a human immunodeficiency virus comprising administering to a diseased patient a pharmaceutical comprising a combination of didanosine and hydroxyurea, characterized in that a pharmaceutical composition according to one or more of the  claims 1 - 17  is administered as a single dose.